BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NEWDEAL HALLU LOCK PLATE SYSTEM

    K Number: K083154 · Decision Jul 10, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    10
    Review Days
    259

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    Basic Information

    Device Name
    NEWDEAL HALLU LOCK PLATE SYSTEM
    K Number
    K083154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Newdeal Sas
    Date Received
    October 24, 2008
    Decision Date
    July 10, 2009
    Product Code
    HRS
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HRS Plate, Fixation, Bone

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    Other Clearances by Newdeal Sas

    K Number Device Name
    K103623 NEWDEAL INTERPHALANGEAL IMPLANT
    K093914 NEWDEAL COMPRESSION PLATES
    K093781 MODIFIED: NEWDEAL HALLU PLATES
    K091788 PANTA NAIL (DIA. 10MM), PANTA NAIL XL
    K091609 NEWDEAL COMPRESSION PLATE
    K073375 NEWDEAL TIBIAXYS SYSTEM
    K071639 QWIX POSITIONING SCREW
    K070447 NEWDEAL COMPRESSION PLATE
    K063831 BASAL DORSAL PLATES